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News & Trends - MedTech & Diagnostics

Pandemic self-testing sparks surge in home screening

Health Industry Hub | January 29, 2024 |

MedTech & Diagnostics News: In an era where access to health screening tests is just a click away, a systemic review from Australian researchers sheds light on the potential drawbacks.

Direct-to-consumer tests can be defined as any in-vitro diagnostic (IVD) test or, more broadly, any medical test using an IVD or medical device, that is marketed directly to consumers without involvement of a healthcare professional. While these tests can enhance patient autonomy and access to healthcare, the debate persists on their validity, impact and public perception.

The University of Wollongong (UOW) research team, led by sociologist Dr Patti Shih from the Australian Centre for Health Engagement Evidence & Values (ACHEEV), explored the diverse array of commercially marketed home tests available to consumers. Distinct from point-of-care testing, national screening programs such as for bowel cancer, and disease-specific monitoring such as for diabetes, the screening tests scrutinised by the researchers primarily target healthy individuals, raising concerns about their efficacy and clinical utility.

“It is a regulatory Wild West at the moment,” said Dr Shih. “There are multiple players in a very large, unregulated market and there’s very little transparency.”

The study identified a staggering 484 test products online, ranging in cost from $12.99 to $1947. However, the findings revealed that only 11% of these tests offer potential clinical utility, that is, they provide useful, meaningful information that is actionable and leads to improvement in the consumer’s health outcomes, according to the researchers. Notably, screening tests for sexually transmitted infections (STIs) were common, addressing barriers to clinical care, particularly in high-risk communities.

Despite these findings, consideration must be given to Australians living in regional and remote communities with limited access to healthcare resources – where distances to medical services are long and the services often expensive. Direct-to-consumer tests can alleviate some of these constraints. COVID-19 rapid antigen tests provide a good example that many people can learn how to perform them at home and interpret the screening test results.

A meta-analysis showed that HIV self-testing increased the uptake of HIV testing by 1.43 times compared to standard of care, increased the mean number of HIV tests by 2.34 during follow-up, doubled the detection of new HIV infections among those tested, and reported higher repeat testing as compared to the control arm. HPV self-testing has also been shown to increase uptake of cervical cancer screening in systematic reviews and meta-analyses. Most women preferred home-based self-sampling vs. sampling at a clinic, quoting privacy, less embarrassment or lower anxiety as the main reasons.

Dr Shih expressed concerns about the UOW’s research findings, highlighting that while 31% of the identified tests serve legitimate roles in clinical diagnosis or treatment, promoting them as home tests raises concerns about potential medical overuse. Examples include tests for prostate-specific antigen (PSA), methylenetetrahydrofolate reductase (MTHFR) gene testing and urine dipsticks for kidney and liver disease, which may generate high false positive rates.

“We also found more than half (56%) did not state that they offered any form of pre or post-test consultation, which is concerning,” Dr Shih explained.

She argued that the harms of commercially marketed screening tests outweigh the benefits, where there is no clinical care coordinated through a healthcare professional. Potential pitfalls include errors, unnecessary diagnoses, and the financial burden of tests that offer little or no clinical benefit. Additionally, the environmental impact of resource-intensive testing and medical waste is a consideration that merits attention.

In response to these findings, Dr Shih called for improved industry regulation and higher standards of evidence to establish the clinical benefit and efficacy of direct-to-consumer tests.

“We would like to see consumer-led reporting systems introduced so patient safety and test results are adequately followed up by health professionals,” she added.

As the direct-to-consumer self testing market continues to grow in Australia, Dr Shih’s research serves as a crucial call to action, urging stakeholders to prioritise patient safety and promote informed decision-making.

In reimagining healthcare across the entire patient journey, Health Industry HubTM is the only one-stop-hub bringing the diversity of Pharma, MedTech, Diagnostics & Biotech sectors together to inspire meaningful change.

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